NCT00867399已完成1 期
A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
研究概览
简要总结
The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects 65 years or greater.
- •Has a MMSE score of 27 or higher.
排除标准
- •History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
- •History of any significant neurological disease.
- •Has an estimated creatinine clearance < 30 mL/min
研究组 & 干预措施
20mg of ABT-126 QD
Active Comparator
20 mg of ABT-126 QD for 10 days
干预措施: ABT-126 (Drug)
30mg and 45mg ABT-126 QD
Active Comparator
30 mg and 45mg of ABT-126 QD for 21 days
干预措施: ABT-126 (Drug)
结局指标
主要结局
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
时间窗: Study Days -1 thru Day 28
Assess the Pharmacokinetics
时间窗: Study Days -1 thru Day 28
次要结局
未报告次要终点
研究者
研究点 (1)
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